187 Regulatory Submissions Jobs

Job Description Job Title: Regulatory Affairs Excellence Specialistu00A0 Job Responsibilities Implements global regulatory strategies and roadmaps by leveraging a comprehensive understanding of the competitive market landscape and product marketing strategy to ensure alignment with organizational objectives. Works under general supervision and broad guidelines, consistently exercising independent judgment on matters of significance, ensuring adherence to company policies and regulatory requirements while maintaining high standards of performance and accountability. Demonstrates substantial understanding of regulator's role in the Quality System with good awareness of product lines, disease states, and customers, possessing general knowledge of business developed through education or past experience. Executes, manages, and prepares U.S. FDA 510(k) pre-market notification submissionsu2014defining regulatory pathways, compiling technical dossiers, coordinating cross-functional inputs, and driving the process through clearance. Prepares and coordinates FDA Pre-Submissions (Q-Subs) when strategic feedback is required, drafting meeting requests and briefing packages, leading interactions with the Agency, and ensuring follow-up actions are completed. Resolves a wide range of moderate complexity requests in creative ways, leads comprehensive safety risk assessments to identify potential safety incidents and regulatory non-compliance, managing these incidents in Trackwise and ensuring corrective actions are effectively implemented. u2022 Monitors and handles potential regulatory impacts on product safety, implementing continuous improvement processes within the regulatory framework and engaging with cross-functional teams to proactively manage regulatory risks. Collaborates with central and regional Regulatory Affairs teams to support establishment registration and listing, and UDI/Global Trade Identification Number (GTIN) related activities, maintaining processes for regulatory filings/ licenses and developing technical contribution. Coordinates and facilitates witness testing to ensure products comply with safety regulations, maintaining direct contact with certification bodies, test houses, and regulatory personnel in local sales organizations. Takes ownership of regulatory planning for new product introductions and product changes, assisting in the maintenance of regulatory compliance throughout the product lifecycle. Supports the development of the regulatory plan, offering guidance on risk assessment and necessary corrective actions to meet regulatory requirements, including product registrations such as CE Marking and clinical evaluations. Develops and facilitates regulatory submissions for both new and existing products/solutions, ensuring accuracy and completeness to expedite regulatory approval processes effectively, preparing regulatory justifications to support submission filing decisions. Creates, reviews, and validates marketing and labeling materials, providing support to projects and other key regulatory initiatives while ensuring compliance with regulatory guidelines and standards. Recommends enhancements in systems and processes to solve problems or improve effectiveness of job area by collaborating with other functions, making periodic or ad-hoc revisions to Regulatory SOPs and templates. Implements safety and compliance requirements for product development projects and OEM/ODM products, communicating and integrating regulatory standards into the I&D organization through memos, training sessions, and deployment strategies. Administers the compliance protocol process within PDLM and MLD, overseeing safety certifications and country-specific approvals to ensure products meet international regulatory standards. Minimum required Education: Bachelor's / Master's Degree in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent. Minimum required Experience: Minimum 8-10 years of experience with Bachelor's in areas such as Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry or equivalent u00A0 About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. u2022 Learn more about . u2022 Discover . u2022 Learn more about . How we work at Philips Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart Our commitment to inclusion and diversity At Philips, we provide equal opportunities to all our employees and to all eligible applicants for employment in our companyu00A0 , irrespective of age, color, disability, nationality, race, religion, gender, sexual orientation (LGBTQ +), and all aspects that make individuals unique. Encouraging diversity and fostering inclusion are key to our mission of improving the lives of 2.5 billion people a year by 2030 through meaningful innovation. We have fair, transparent, and clear employee policies which promote diversity and equality, in accordance with currently applicable law.u00A0 For, we believe that life is better when #youareyou. Our hybrid working model is defined in 3 ways: There's a certain energy when everyoneu2019s in the same room that can heighten idea generation and creative friction needed for problem-solving. Choosing where, when and how to work can vary according to task and team schedules. Flexibility isnu2019t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis. The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. Why should you join Philips Working at Philips is more than a job. Itu2019s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

Job Location - Chennai & Hyderabad Keywords Safety Systems, Regulatory submissions, labeling, publishing, RIMS (Veeva, etc.) Roles and Responsibilities Must Have Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Regulatory Sciences, or Computer Science. 4–8 years of experience in IT testing/validation, with 2–4 years in Regulatory Affairs systems Work with Regulatory Affairs, Publishing, Labeling, and IT teams to understand business processes and URS (User Requirement Specifications). Hands-on experience with Regulatory applications (e.g., Veeva Vault RIM, Lorenz docuBridge, Liquent InSight, Extedo eCTDmanager, or similar). Develop UAT strategy, test plans, test cases, and traceability matrices aligned with RA workflows. Execute UAT test scripts, document results, log defects, and track resolution with IT/vendors. Validate workflows related to submission planning, document authoring, publishing, eCTD compilation, electronic submissions, and labeling/artwork review. Perform regression testing for system upgrades, patches, and integrations with DMS, QMS, Safety, and Clinical systems. Verify compliance with 21 CFR Part 11, GAMP 5, ICH, and regional regulatory submission guidelines. Validate metadata management, version control, and controlled vocabularies for submissions. Ensure readiness for global submissions (NDA, MAA, IND, CTA, ANDA, variations, renewals). Support end-user readiness, training, and sign-off for UAT completion. Document deviations, manage defect triage, and ensure timely closure. Provide UAT summary reports, support release readiness decisions, and maintain audit trail. Contribute to audit/inspection readiness by maintaining UAT documentation. Identify process improvement opportunities and support test automation initiatives. Good to Have (secondary skills) Strong knowledge of Regulatory submissions, eCTD structure, publishing workflows, labeling, and lifecycle management. Experience with UAT methodology, SDLC, and CSV (Computer System Validation). Familiarity with global regulatory guidelines (FDA, EMA, MHRA, PMDA, Health Canada). Proficiency with defect tracking tools (JIRA, HP ALM, Veeva QMS). Excellent communication, documentation, and cross-functional collaboration skills. Strong analytical and problem-solving mindset. Communication Immaculate communication and handles multiple clients/ projects Works in Consulting capacity Regulatory Affairs Applications Best Regards, Sanjay Kumar

Role Overview: As a Lead Statistical Programmer, you will be responsible for overseeing programming activities for clinical trials, regulatory submissions, and integrated analyses. Your role will involve leading a team, ensuring high-quality deliverables, and developing efficient programming standards to support drug development. Key Responsibilities: - Lead statistical programming activities for a compound or therapeutic area. - Manage, mentor, and guide a team of statistical programmers. - Create and validate analysis data sets (ADaM), tables, listings, and figures (TFLs) following CDISC standards. - Develop and validate Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) reports. - Ensure accuracy and consistency across clinical studies and integrated data. - Develop, test, and implement reusable standard programs and SAS macros to automate routine tasks. - Prepare reviewer guides, data definition documents, and other materials for regulatory filings. - Collaborate with cross-functional teams including Statisticians, Clinical Data Management, Medical Writing, Regulatory, and Clinical Operations. - Accurately estimate programming efforts and ensure timely project delivery. Qualification Required: - Strong proficiency in SAS programming; experience with R preferred. - In-depth knowledge of CDISC standards (ADaM, SDTM). - Experience with regulatory submissions (FDA, EMA) and clinical study lifecycle. - Knowledge of therapeutic areas such as Oncology, Immunology, Neuroscience. - Strong communication and leadership skills to guide teams and manage stakeholders. - Ability to handle multiple priorities and deliver high-quality results under deadlines.,

Role Overview: ApoPharma, a member of the Apotex group of companies, focuses on discovering and developing new medicines to improve the quality of life for patients with debilitating and life-threatening diseases. The company's major research focus is on investigating the pathological role of iron in human disease and utilizing novel medicines to treat conditions affected by iron. Key Responsibilities: - Prepare quality post-launch Product Life-Cycle Management (PLCM) packages for different markets to ensure timely approval. - Maintain and complete regulatory documents promptly to ensure compliance in various markets. - Coordinate and compile deficiency responses in a timely manner, working with other functional areas to resolve issues related to regulatory submissions. - Evaluate and prepare post-approval supplements to manage the regulatory product life-cycle as required. - Review change control documents, provide accurate assessments for changes, and maintain regulatory databases with accurate information. - Coordinate with third-party manufacturers for document requirements for regulatory submissions. - Act as a backup for team members and provide support when necessary. - Communicate and follow up with departments for compilation and submission of PLCM submissions and query responses according to agreed timelines. - Ensure compliance with SOPs, RA policies & procedures, and regulatory guidelines, and interact with other departments to discuss and resolve regulatory issues. - Communicate with external sources such as agents and suppliers to request or provide relevant data for submissions. - Seek guidance from team members to enhance regulatory knowledge, work collaboratively towards achieving outcomes, and demonstrate organizational values. - Adhere to all compliance programs and policies, including Global Business Ethics, Quality, Safety, Environment, and HR policies. - Perform any other relevant duties as assigned. Qualifications Required: - Education: Post-graduate/graduate degree in Chemistry, Pharmacy, or Life Sciences. - Knowledge, Skills, and Abilities: Familiarity with post-approval change submission requirements and compilation of variation packages for US, Canada, EU, Australia/New Zealand, and other markets. - Experience: Minimum 1 year of experience in the US, Canada, EU, Australia/New Zealand, and other markets. (Note: The additional details of the company were not explicitly mentioned in the provided job description.),

Role Overview: As a Lead Statistical Programmer in the clinical data field, you will be responsible for overseeing programming activities related to clinical trials, regulatory submissions, and integrated analyses. Your role will involve leading a team, ensuring the delivery of high-quality work, and establishing efficient programming standards to support drug development. Key Responsibilities: - Lead statistical programming activities for a compound or therapeutic area. - Manage, mentor, and guide a team of statistical programmers. - Create and validate analysis data sets (ADaM), tables, listings, and figures (TFLs) following CDISC standards. - Develop and validate Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) reports. - Ensure accuracy and consistency across clinical studies and integrated data. - Develop, test, and implement reusable standard programs and SAS macros to automate routine tasks. - Prepare reviewer guides, data definition documents, and other materials for regulatory filings. - Collaborate with cross-functional teams including Statisticians, Clinical Data Management, Medical Writing, Regulatory, and Clinical Operations. - Accurately estimate programming efforts and ensure timely project delivery. Qualification Required: - Strong proficiency in SAS programming with experience in R preferred. - In-depth knowledge of CDISC standards (ADaM, SDTM). - Experience with regulatory submissions (FDA, EMA) and the clinical study lifecycle. - Knowledge of therapeutic areas such as Oncology, Immunology, Neuroscience. - Strong communication and leadership skills to guide teams and manage stakeholders. - Ability to handle multiple priorities and deliver high-quality results under deadlines.,

As a Statistician I at YouV, you will play a crucial role in conducting statistical analysis for clinical trials, contributing to the interpretation of study results, and ensuring data quality and integrity. Your responsibilities will include: - Assisting in statistical analysis for clinical trials. - Performing data cleaning and validation. - Generating summary tables, figures, and listings. - Assisting in the development of statistical analysis plans and study protocols. - Collaborating with cross-functional teams to ensure data quality and integrity. - Contributing to the interpretation of study results. - Staying updated with relevant regulations and industry best practices. Qualifications required for this role include: - Education: Masters degree in Statistics, Biostatistics, or a related field. - Experience: Minimum of 1-2 years of industry experience as a Statistician within the Life Sciences industry or Contract Research Organization (CRO). - Proficiency in statistical analysis using SAS or R. - Familiarity with clinical trial protocols and statistical analysis plans. - Strong data interpretation and presentation skills. - Ability to work collaboratively in a team environment. Join us at YouV and be part of a collaborative, open-door, and inclusive environment where you will have the opportunity to learn beyond your designation and grow your skills. Experience a unique blend of warmth, positivity, and professional development.,

Regulatory Affairs Management- Understands the regulatory framework, including regional trends, for various types of applications and procedures for biological therapeutic products (Biologics, Biosimilar, Novel Biologics and Vaccines) in India and ROW markets. Provides regulatory input on procedural and documentation requirements as defined by Health Authorities such as Indian regulatory authority, Emerging markets and ROW countries. Review of documents (e.g. RCGM-PCS, CTA, MAA, PAC, response documents, study protocols, regulatory maintenance documents, PSURs, etc.). Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product. Uses and shares best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment. Leads and / or contributes to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions. Liaises closely with cross-functional members with aligned product responsibilities. Develops, completes and maintains submission delivery plans, submission content plans, and proactively provides status updates of the ongoing projects within the organization. Coordinates the input, maintenance and revision in the project planning tools for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to function head. Supports operational team and Project team w.r.t to regulatory requirements. Provides coaching, mentoring and knowledge sharing within the team. Contributes to process improvement. Minimum Requirements Education and Experience Relevant University Degree in Science or related field Minimum 10-16 years of relevant Regulatory experience within the biopharmaceutical industry, including experience in CTA, MAA, PAC and ROW markets for Biological and Biosimilar products and general knowledge of drug development Good knowledge of the regulatory product maintenance process Strong project management skills Leadership skills, including experience leading multi-disciplinary project teams. Preferred Experience Regulatory affairs experience across a broad range of markets. Having experience in Regulatory information management system Handled regulatory deliverables at the project level Experience of working with people from locations outside of India, for Emerging and ROW markets. Skills and Capabilities Excellent English written and verbal communication skills Cultural awareness Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions Proficiency with common project management (e.g., MS Project) and document management tools Ability to work independently and as part of a team Influencing and collaborator management skills Ability to analyse problems and recommend actions Continuous Improvement and knowledge sharing focused Operations/Manufacturing organisation (CMC post approval) Marketing Companies/Local affiliates Reporting Relationship Direct Reports – 2-4

We are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates, partners, and health authorities to ensure timely approvals and post-approval compliance. Key Responsibilities: Prepare, review, and submit regulatory dossiers (CTD/eCTD or country-specific formats) for biosimilars in Emerging Markets. Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, CIS countries, ASEAN, LATAM, and Africa. Support product registrations, renewals & variations. Ensure proper submission planning and regulatory timelines to support product launches and lifecycle management. Respond to health authority queries in coordination with CMC, clinical, and quality teams. Maintain a regulatory dashboard, submission tracker, and repository of country-specific requirements and timelines. Understand local regulatory pathways for biosimilars/biologics: reliance, abridged reviews, priority review, etc. Familiarity with GCC-CTD, ASEAN CTD, and regional WHO biosimilar guidelines. Experience working with local affiliates or partner companies in Emerging Markets. Prior exposure to biosimilar guidelines in WHO, GCC, SAHPRA, INVIMA, ANVISA, etc. Experience with regional electronic submission platforms. Qualifications: Bachelors or Masters degree in Life Sciences, Pharmacy, Biotechnology, or related field. Proven track record in filing and obtaining approvals for biologics/biosimilars in Emerging Markets. Knowledge of CTD structure, Module 1 customization, and regional submission formats. Strong project management, communication, and stakeholder coordination skills Show more Show less

As an Associate Statistician at our organization, your role will involve assisting in conducting statistical analysis for clinical trials. You will be responsible for performing data cleaning and validation, as well as generating summary tables, figures, and listings. Additionally, you will collaborate with cross-functional teams to ensure data quality and integrity, contribute to the interpretation of study results, and stay updated with relevant regulations and industry best practices. Your qualifications should include a Bachelor's degree in Statistics, Biostatistics, or a related field. You will have the opportunity to work under the guidance of senior statisticians, conduct statistical analysis, perform data management tasks such as data cleaning and transformation, and assist in generating analysis datasets and statistical outputs. Collaboration with programmers and data managers to ensure data quality and consistency will also be a key part of your responsibilities. Furthermore, you will contribute to the development and review of study documents and regulatory submissions, participate in departmental meetings and training programs, and stay informed about emerging statistical methodologies and industry trends. Our organization values teamwork, co-creation, and co-execution, providing a supportive and inclusive work environment where you can learn and grow beyond your designated role. Join us in making work meaningful together and be a part of a culture that promotes warmth, positivity, and collaboration.,

Tracking of Regulatory emails and ensuring revert has been provided to Exchange Insider Trading Regulation Approvals Advertisement approvals Regulatory Submissions - Exchanges and Depositories ================================================= Educational Qualifications: Graduate/Post Graduate Experience: 5 to 6 year experience in Broking firm Domain Knowledge: Broking Industry, SEBI Regulations NISM IIIA to be cleared mandatorily

Location: Gurgaon Regulatory and Safety Affairs is a critical function within R&D: a key partner in developing the right portfolio strategy for brilliant innovation, activation in our markets and secure the products during all product life cycle. We actively engage externally with stakeholders and regulators to anticipate and credibly influence changes to the regulatory environment, and we bring that regulatory intelligence back to Reckitt to drive better informed business decisions. We lead the thinking internally about what is possible and put forward ideas that become reality, acting as stewards of our brands and our company to deliver compliant and competitively positioned products to the people we serve. Data, and data accuracy Is a foundational element of regulatory processes and directly influences the effectiveness of the organisation and its ability to deliver compliant and competitively positioned products. As Regulatory Operations Specialist Publishing you will be responsible for the compilation and publishing of all regulatory data packages required across the product lifecycle stages, initially focused on the global medicinal portfolio and will reach further into other classifications once established. In your role you will be responsible for the quality, accuracy, and timely population of data within the key business systems which support publishing activities. You will become a subject matter expert in the use of these systems and the business processes which support them. You will partner with the wider Operations Regulatory team to understand and meet its publishing needs. You will lead reviews with the wider Operations Regulatory team to feed back on publishing activities ensuring we deliver to key stakeholders in areas such as accuracy, timeliness etc. Where required, and in conjunction with the wider Operations Regulatory teams, you will use continuous improvement methodology to improve internal business processes and systems which support Publishing activities. You are proficient in the field of publishing, and you will use your experience to execute your role effectively and to a high level of compliance with the applicable standards and external industry expectations. You will play an important role because. We’re proud of our organisation and continually strive to be the best that we can be. The Regulatory Operations - Publishing plays an essential role in leading a team that deliver critical services to the broader Regulatory Operations function. You will succeed because ... You bring prior experience in the field of regulatory publishing, with a strong track record of successful delivery. You are skilled in the identification of key stakeholders and have a strong capability for building mutually beneficial partnerships based on openness and transparency. Have good communication skills and capability to keep key stakeholders consistently informed and updated across a broad range of subjects and processes in real time. You have broad knowledge of regulatory processes, with particular emphasis on medicines, but experience in other classifications is considered beneficial. You have knowledge of the medicinal dossier structure and regulations / guidance for global markets, medicinal publishing requirements, document repositories, common validation publishing challenges, and management of sequences and submission tracking throughout the product lifecycle. You will have knowledge of the worldwide publishing standards including, Nees, ACTD, eCTD, US, Swiss and South Africa Have knowledge or experience in the use of publishing tools / solutions such as Lorenz Documbridge etc. Ability to consistently deliver to time, cost and quality standards in a high-pressure environment. Demonstrates courage and empathy and work collaborative cross-functional, through change by adopting a growth and compliance mindset and inclusive/expansive leadership. Key Responsibilities of the Role will include Responsible for delivering all publishing activities on time and to a high-quality standard. All publishing activities includes: collating all required documents, compilation, validation of all modules and publishing of the dossier/ensuring the submission package is ready for publishing. Fostering productive relationships with those stakeholders critical to your role and maintaining high level of communication to ensure buy in and engagement. You will apply the principles of continuous improvement to consistently and critically review internal processes to identify and deliver increased efficiency, compliance or other business benefit. Training your publishing team to a high level of knowledge and competency in publishing processes. Deliver regular updates on work deliveries, transparency in the execution plans and dates, project management alongside reg ops teams.

Role & responsibilities Hiring candidates with experience in CMC Regulatory Affairs in Pharmaceutical Industry across regulated and semi regulated regions with hands on experience into - Preparing submission content plans for CMC submissions including, post approval changes, renewals, product renewals, Module 3 baselines, and annual report/notifications. Execute regulatory team activities as directed to achieve submission approval for products in regulated and semi regulated regions. Review quality documents for post approval submissions as above. Author high quality Module 3 and Module 2 section /summaries. Maintains the general knowledge of CMC/M3 regulations and guidance for Injectables. Coordinate with stake holders (R&D, Plant and suppliers) for sourcing of documents and review of executed documents received. Perform data entry within the regulatory databases. Report and escalate incidents as situation demand. Carry out the activities as per assigned by the immediate supervisor from time to time, for which he/she is authorized as per the SOP trainings. In depth understanding of Health Authority expectations for pharmaceutical types for the regulated and semi regulated regions. Must possess organization skills, time management skills and attention to details. Must possess strong communication skills, critical thinking, interpersonal skills and interpretation skills. Should understand business presentation and communicate descriptions of problems and solutions. Preferred candidate profile M Pharm, M Sc or B Pharm with min. 2 to 6 years experience in CMC Regulatory Affairs in Pharmaceutical Industry across regulated and semi regulated regions. Work experience into sterile/ parenteral products would be an added preference.

You will be responsible for developing, validating, and applying pharmacokinetic and pharmacodynamic models (PopPK and PBPK modelling) to support drug development programs. This includes conducting and presenting pharmacokinetic modelling and simulation (M&S) analysis to management and technical teams for project advancement. You will also predict human pharmacokinetics based on in-silico, in-vitro, and in-vivo data, including dose scaling and profile prediction. Additionally, you will conduct IVIVE and IVIVC and work closely with cross-functional teams, including preclinical, clinical, and regulatory teams, to guide decision-making and project direction. Utilizing software tools such as WinNonlin, R, SAS, Matlab, Monolix, GastroPlus, Simcyp, PK-Sim, and other similar platforms for M&S will be an essential part of your role. Furthermore, you will be expected to develop and optimize models for bioequivalence studies, sample size determination, and regulatory submissions. Supporting regulatory filings for New Chemical Entities (NCE), 505(b)(2), and generic products will also be within your responsibilities. Your focus will be on engaging in all aspects of drug development with an emphasis on predicting human pharmacokinetic and pharmacodynamic behavior under different dosing regimens. Using advanced statistical approaches for bioequivalence analysis and large-scale data handling, you will collaborate in the development and refinement of methodologies and approaches in PK modelling. It is crucial to ensure clear communication of findings through presentations and written reports using Microsoft Excel, Word, and PowerPoint. Qualifications: - M. Pharm / Ph. D Amneal is an equal opportunity employer and does not discriminate based on caste, religion, gender, disability, or any other legally protected status. The organization values diversity and inclusion in the workplace. The Human Resources team at Amneal partners with all aspects of the organization, driving success through effective and innovative management of people for both current and future business needs. Their key roles include: - Executive Role: Specialists in all aspects of people management providing high-level input at a strategic level into all key business decisions. - Audit Role: Ensuring all areas of the organization are compliant with legal requirements and best practice employment policies and procedures. - Facilitator Role: Close partnership to support, advise, and extend the ability of all areas of the organization to meet their objectives through highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing. - Consultancy Role: Providing expert advice to the organization and its managers on any aspect of workforce management, employee relations, and performance. - Service Role: Ensuring the organization is fully aware of and equipped to deal with developments impacting employment matters, such as changes in legislation and characteristics of the labor market.,

Job Title: Study Start-up and Regulatory Submission Manager Location: Navi Mumbai, India Experience Required: 5 10 years Employment Type: Full-Time Working Days: 2nd & 4th Saturdays; All Sundays Off Job Description We are seeking an experienced Study Start-up and Regulatory Submission Manager to join our clinical operations team in Navi Mumbai. The ideal candidate should have strong expertise in India-specific clinical trial operations , with proven experience managing regulatory submissions and study start-up activities . Key Responsibilities: Lead and manage Clinical Trial Applications (CTA) and regulatory submissions in compliance with Indian regulatory requirements. Drive clinical study start-up activities , including site identification, feasibility, and activation. Coordinate with ethics committees and clinical trial sites to ensure smooth and timely approvals. Prepare, review, and submit study-related documents to DCGI (Drug Controller General of India) and other relevant authorities. Ensure compliance with ICH-GCP guidelines, local regulations, and company SOPs throughout the process. Collaborate with cross-functional teams to ensure on-time study initiation. If you or someone you know fits this role, apply directly through the job post or share your resume at navya_b@trigent.com

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe. You will perform allied activities such as data collection for report planning, developing strategy, and leading kick-off meetings and round table discussions for comment resolution. Additionally, you will write various safety reports (or part of such reports) for global regulatory submissions, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Report, Risk Management Plans, and other documents. It will be your responsibility to take ownership of the assigned deliverables and collaborate with internal/client stakeholders and the client to obtain the required inputs. You will also perform quality reviews of safety reports prepared by junior or associate medical writers. Your role will involve authoring or contributing to ad hoc reports, benefit-risk evaluation reports, justification/supporting documents for label updates, and writing Common Technical Document Summaries including Non-Clinical and Clinical Overviews, Clinical Summaries, and other regulatory documents as assigned. You will also prepare medical information responses for Healthcare Providers (HCPs) and contribute to signal reports (ad hoc & periodic) and safety issue analysis reports. Writing subject narratives for adverse drug reactions and serious adverse events will be part of your responsibilities. Internal and external (client) communication and coordination to gather the necessary inputs will be essential in this role. You will participate in creating and updating labels, such as Core Data Sheets, USPI, centralized SPCs, and Med Guides. Conducting literature searches for authoring various types of reports or routine surveillance activities will also be part of your duties. Reviewing and proposing updates to search strategies and articles selected by other medical writers/junior writers will be necessary. Additionally, you will author literature abstracts/summaries and propose Company comments. You will be expected to implement and promote the use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures. Ensuring compliance of operations with governing regulatory requirements will be paramount. Creating, maintaining, and fostering a culture of high customer service will also be part of your responsibilities. Any additional activities as per the project requirement or managers" discretion upon completion of relevant training will also need to be performed. Embracing a collaborative workspace where personal growth is nurtured will enable you to make a meaningful global impact. Fortrea is actively seeking motivated problem-solvers and creative thinkers who share the passion for overcoming barriers in clinical trials. The commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Joining the exceptional team at Fortrea will provide you with the opportunity to contribute to a culture where personal growth is encouraged and where you can make a significant global impact. For more information about Fortrea, visit www.fortrea.com. Fortrea is proud to be an Equal Opportunity Employer. For more information about how personal data is collected and stored, please refer to the Privacy Statement. If you require a reasonable accommodation to complete your job application, pre-employment testing, job interview, or to participate in the hiring process due to a disability, please contact taaccommodationsrequest@fortrea.com. Please note that this email address is only for job seekers requesting an accommodation and should not be used to check the status of your application.,

Position- Executive/Sr. Executive Dept.-Regulatory Affairs Key Responsibilities Act as the first point of support for Business Development Managers on product-related queries from India. Coordinate and organize audits of supplier production facilities to ensure compliance with international standards. Gain exposure to and support during international regulatory audits (USFDA, WHO, ANVISA, EDQM). Understand and translate client quality parameters for raw materials, ensuring supplier adherence. Monitor supplier manufacturing processes for compliance with national and global standards. Assist in preparing and managing documentation for specification setting, change controls, regulatory submissions, annual product reviews, and investigations with suppliers. Maintain up-to-date knowledge of regulatory requirements across different zones and international guidelines. Support clients during factory audits and commercial visits to supplier facilities. Collaborate with cross-functional teams to aid organizational growth and business development. Ensure timely completion of regulatory submissions and strict adherence to quality standards. Represent the organization at national and international exhibitions. Participate in continuous training programs to upgrade skills and regulatory knowledge. Qualifications & Skills Bachelors or Masters degree in Pharmacy, Life Sciences, or a related field. 25 years of experience in Regulatory Affairs, Quality Assurance, or Compliance (pharmaceutical/chemical industry preferred). Strong understanding of international regulatory guidelines (USFDA, WHO, ANVISA, EDQM). Experience in supplier audits and compliance monitoring. Excellent communication, coordination, and stakeholder management skills. Strong attention to detail and ability to work under strict timelines. Willingness to travel for audits, client visits, and international exhibitions.

Role & responsibilities Job description Perform protocol for drug excipient compatibility studies and submit the protocol for review and approval Complete lab. experiment hands-on independently (Lab scale to exhibit batch and query handling). Dosage forms experience: Injectables predominantly more than 90% in career. Perform formulation development activities on differentiated formulations and innovative technologies as part of product development. Carry out /Support Scientific literature search (CVM/USFDA/Daily-med/publications). Follow good laboratory practices, good documentation practices (online LNB writing) and maintain the logbooks and forms for equipment/instruments. Compilation, interpretation and review of analytical results and stability data Maintain records of formulations, batch processes, and stability studies. Proficient in drafting, reviewing, and managing technology transfer document (MFR, MPR, stability protocols, justification of specifications etc. as part of TT). Exposure in oral liquids and oral solid dosage forms will have an added advantage Preparation of quality-based product development reports (PDR). Evaluation of alternate vendor Experience in preparing technical and regulatory submissions. Coordinate outsourced activities at the partner site by a regular communication plan. Provide timely technical inputs and timely escalation to ensure successful task completions. Communicate effectively with R&D, production, QA/QC, supply chain teams clients, vendors, and stakeholders regarding project progress and requirements. Qualifications M. Pharm or Ph.D. in Pharmacy with minimum industrial experience of 2 to 5 years in pharmaceutical development and scale-up of products. Support in Technical troubleshooting/ root cause identification/ Investigation/Corrective Action and Preventive Action pertaining to product development or manufacturing activities.

As a Regulatory Affairs Manager at Vibcare Healthcare, a leading pharmaceutical manufacturer committed to enhancing health outcomes through innovative and quality assured pharmaceutical products, your primary responsibility will be ensuring regulatory compliance, managing regulatory requirements, overseeing regulatory submissions, and maintaining the quality system. You will play a crucial role in upholding unparalleled transparency and quality in all our offerings, certified by WHO-GMP standards. To excel in this role, you should possess expertise in regulatory compliance, regulatory requirements, regulatory affairs, regulatory submissions, and quality system management. Your strong attention to detail and analytical skills will be essential in navigating the complex regulatory landscape of the pharmaceutical industry. Effective communication and organizational skills are also key as you collaborate with internal teams and regulatory authorities to streamline processes and ensure compliance. This is a full-time on-site position based in Panchkula, offering the opportunity to work with a dedicated team that is passionate about empowering health. If you have a Bachelor's degree in pharmacy, life sciences, or a related field, along with experience in the pharmaceutical industry, we invite you to join us in our mission to make a positive impact on healthcare.,

As a leading global contract research organization (CRO) dedicated to scientific excellence and backed by years of expertise in clinical development, Fortrea offers a diverse array of clinical development, patient access, and technology solutions in over 20 therapeutic areas. Operating in approximately 100 countries, Fortrea is revolutionizing drug and device development worldwide. Your responsibilities will include performing various tasks such as generating reports from databases or safety systems, managing data requests, conducting sales data calculations, and conducting regulatory website searches. You will also have the opportunity to contribute to different safety reports for international regulatory submissions, including Annual Reports, Periodic Safety Update Reports, and other related documents. Your role will involve developing report sections, reviewing line listings, preparing case narratives, and participating in comment resolution discussions. Additionally, you will support medical writers in signal detection activities by assisting with data cleaning, reviewing line listings, and creating materials for signal review meetings. Fortrea is actively looking for individuals who are motivated problem-solvers and innovative thinkers eager to tackle challenges in clinical trials. Our primary goal is to transform the development process and facilitate the rapid delivery of groundbreaking ideas and treatments to patients in need. By joining our exceptional team, you will be part of a collaborative environment that fosters personal growth and enables you to contribute to a significant global impact. Fortrea is an equal opportunity employer that values diversity and inclusion in the workplace. To learn more about Fortrea and our commitment to excellence, please visit www.fortrea.com. For information regarding the collection and storage of personal data, please refer to our Privacy Statement. If you require a reasonable accommodation during the job application process, pre-employment testing, or job interview, or need assistance to participate in the hiring process, please contact taaccommodationsrequest@fortrea.com. Kindly note that this email address is exclusively for job seekers requesting accommodations and should not be used to inquire about application status.,

About the Opportunity Job Type: Fixed Term Contractor Contract duration : 7 months. Application Deadline: 08 September 2025 Job Description Title Senior Associate - GCSS Operations Department General Counsel Shared Services Location India Reports To Manager, GCSS Operations Level Grade 3 We're proud to have been helping our clients build better financial futures for over 50 years. How have we achieved this By working together - and supporting each other - all over the world. So, join our General Counsel Shared Services team and feel like you're part of something bigger. General Counsel (GC) is a trusted advisor to all parts of FIL, providing high-value independent advisory and assurance expertise through our specialist teams. GC comprises of Legal, Risk, Compliance, Tax, and Public Policy & Strategic Relationship Management. General Counsel Shared services (GCSS) function is a global centre of expertise currently being built out in Dalian and India. It provides operational support and services to the General Counsel function. Manage day-to-day KYC team operations, providing guidance and support. Conduct periodic reviews and updates of KYC policies and procedures to address regulatory changes and emerging risks. Maintain and enhance the compliance framework for regulated activities. Ensure the delivery of regular compliance audits and timely regulatory submissions. Prepare and distribute compliance reports, including Errors, Complaints & Breaches logs. Support AML/KYC procedures and oversee new business acceptance processes. Prepare and present reports at Board Meetings as required. Collaborate with cross-functional teams to ensure alignment in KYC processes. Establish best practices and standard operating procedures for KYC that comply with industry standards. Manage KYC requests, acting as the liaison between external organisations and internal stakeholders. Provide support for business, operational, and regulatory change projects. Maintain and manage stakeholder relationships, including global Company Secretaries. Ensure adherence to the FIL Code of Ethics. Manage and prioritise requests received via the team mailbox. Develop and deliver regular reports containing KYC statistics. Assist in streamlining existing processes and supporting ongoing projects and system enhancements. Experience and Qualifications Required Bachelor's degree in finance, business, law or a related field. Master's degree or professional certification preferred. Minimum of 3 years of experience in KYC compliance within the financial services industry with a proven track record of progressively increasing responsibility. Ability to adapt to changes and manage multiple priorities effectively. Experience or knowledge in General Counsel functions, Risk/Compliance, and AML/KYC regulations is advantageous. In-depth knowledge of AML, KYC and other relevant regulatory requirements on a global scale. Strong leadership and managerial skills with the ability to motivate and develop a high performing team. Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders. Analytical mindset with the ability to assess complex situations, identify risks and develop practical solutions effective at a global level. Proven ability to navigate and adapt to a fast-paced, dynamic work environment. Feel rewarded For starters, we'll offer you a comprehensive benefits package. We'll value your wellbeing and support your development. And we'll be as flexible as we can about where and when you work - finding a balance that works for all of us. It's all part of our commitment to making you feel motivated by the work you do and happy to be part of our team. For more about our work, our approach to dynamic working and how you could build your future here, visit careers.fidelityinternational.com. For more about our work, our approach to dynamic working and how you could build your future here, visit careers.fidelityinternational.com.

Job Description: As a Regulatory Affairs Manager at McW Healthcare, you will play a crucial role in ensuring regulatory compliance and maintaining quality systems in our pharmaceutical company based in Indore. Your responsibilities will include handling regulatory requirements, submissions, and overseeing day-to-day operations related to regulatory affairs. To excel in this role, you should possess strong skills in regulatory compliance, regulatory requirements, and regulatory submissions. A deep understanding of quality systems is essential to maintain the high standards of our WHO approved facility. Attention to detail and analytical abilities will be key as you navigate the complexities of regulatory processes. Effective communication and interpersonal skills are vital for successful interactions with regulatory authorities and internal stakeholders. Your educational background should include a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related field. Possessing relevant certifications in Regulatory Affairs would be advantageous in carrying out your duties effectively. Join us at McW Healthcare to contribute to our mission of enhancing global health through innovative pharmaceutical products. Be a part of a dynamic team dedicated to improving human health and quality of life worldwide.,

The Associate Director Biostatistics position based in Ahmedabad requires a candidate with an MSc or PhD in Biostatistics/Statistics and at least 12 years of experience in CROs, Bio-tech, Pharma, or Biopharmaceuticals. As an Associate Director Biostatistics, your main responsibilities will include leading and overseeing all statistical activities for clinical studies. This involves tasks such as study design, analysis plans, reporting, and publications. You will be managing a team of statisticians and programmers to ensure the timely delivery of high-quality work. Additionally, you will provide statistical input on protocols, sample size calculations, and randomization schemes, as well as develop and review statistical analysis plans and related programming. In this role, you will be responsible for interpreting and reporting study data, supporting regulatory responses, and contributing to global submissions. Furthermore, you will play a key role in mentoring and training team members to create a high-performance work environment. You will also represent the company in sponsor meetings, DSMB meetings, and regulatory discussions. The ideal candidate for this position should possess strong leadership, problem-solving, and mentorship skills. Proficiency in statistical tools such as SAS, R, and other software used in life sciences is essential. Experience in regulatory submissions and CDISC standards is also a requirement. Excellent communication, business writing, and presentation skills are crucial for this role, along with the ability to manage multiple projects under tight deadlines. This is a full-time position that requires the candidate to work on-site in Ahmedabad. If you meet the qualifications and are interested in this opportunity, please send your application to maaz@Shamrockvalue.com.,

You are an experienced Associate Director - Biostatistics who will be joining a leading client in the pharmaceutical industry. Your role will be crucial in clinical development, involving tasks such as contributing to trial design, analysis planning, interpretation of results, and regulatory submissions. Your key responsibilities will include collaborating on innovative and efficient clinical trial designs to ensure alignment with study objectives. You will independently author and review protocols, statistical analysis plans, and clinical study reports. Providing statistical leadership in regulatory interactions, publications, and presentations will also be part of your role. Additionally, you will manage multiple studies to ensure consistency and adherence to industry standards. Your expertise in statistical methodologies and clinical trial design will be applied within a dynamic development environment. You will act as a strategic partner in cross-functional teams, contributing to drug development strategies. It is essential to maintain compliance with processes, SOPs, and global project standards. Furthermore, you will have the opportunity to mentor and develop team members while fostering a collaborative and inclusive culture. The ideal candidate for this role should have extensive experience in biostatistics within clinical development. Strong knowledge of statistical methods and regulatory requirements is required. You should also possess the ability to communicate complex statistical concepts to cross-functional teams and demonstrate proven leadership skills with a collaborative mindset. This is an exciting opportunity to work with a leading pharmaceutical company in an innovative and data-driven environment. If you are passionate about biostatistics and eager to make a meaningful impact, we encourage you to connect with us! Feel free to reach out for more details or apply today.,

Job Description Pharma Regulatory Affairs Manager Location: Pune, Maharashtra Department: Regulatory Affairs Reports To: Head – Regulatory Affairs / Senior Leadership Job Overview We are seeking a highly skilled and experienced Pharma Regulatory Affairs Manager to ensure compliance with global regulatory requirements and to support the successful development, approval, and commercialization of pharmaceutical products. The ideal candidate will bring deep expertise in regulatory affairs, strong leadership in navigating complex regulatory landscapes, and the ability to collaborate effectively with internal teams and regulatory authorities. Key Responsibilities Develop and implement regulatory strategies to ensure compliance with international and regional regulations . Prepare, review, and submit regulatory documents in line with global requirements (US, EU, and emerging markets). Liaise with regulatory authorities to address queries and obtain timely approvals. Monitor evolving regulatory guidelines and industry trends , assessing their impact on product development and commercialization. Partner with R&D, Quality, Clinical, and Legal teams to provide regulatory insights throughout the product lifecycle. Support documentation for clinical trials , including protocols, investigator brochures, and informed consent forms. Conduct risk assessments and provide recommendations for safety reporting and compliance obligations. Participate in audits and inspections , driving corrective and preventive actions as needed. Provide regulatory training and guidance to internal stakeholders to enhance compliance awareness. Qualifications & Requirements Education: Bachelor’s degree in Pharmacy or a related scientific field (Master’s preferred). Experience: 7 - 8 years in pharmaceutical regulatory affairs within a global organization. Strong knowledge of FDA regulations (21 CFR Part 11), ICH guidelines, EMA, and regional market requirements . Demonstrated success in regulatory submissions leading to product approvals. Proven project management skills , with the ability to manage multiple projects in a dynamic environment. Excellent written and verbal communication skills for engaging internal teams and external authorities. Strong analytical, problem-solving, and decision-making abilities. Proficiency in regulatory information management systems and related tools.

Regulatory affairs professional with experience in managing product listings for different markets and ensuring full compliance with all regulations. Proven track record of collaborating with renowned global cosmetic brands to navigate and meet regulatory requirements across multiple regions, including the USA, Canada, Australia, New Zealand and Middle East. Proficient in cosmetic regulations, including several regulations and versed with interpreting and applying recent regulatory updates. Highly skilled in managing compliance with state-specific regulations. Adept at leading cross-functional teams to support regulatory submissions and ensure product compliance, driving efficiency and market access. Ensure compliance with local and international cosmetic regulations, including ingredient restrictions, labeling, and claims. Ensure compliance with local and international cosmetic regulations, including ingredient restrictions, labeling, and claims. Stay updated with regulatory changes and proactively implement necessary product or process changes.